Description

Trazodone Impurity A is a designated impurity standard used in the analytical profiling and quality control of the antidepressant drug, Trazodone HCl. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. It serves as a key reference standard for method development, validation, and routine testing in pharmaceutical quality assurance and research & development.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Trazodone Impurity A in Trazodone HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Essential for pharmaceutical research and development (R&D), aiding in the study of degradation pathways and impurity formation.
• Critical component in analytical method development and validation for HPLC, UPLC, and GC techniques.
• Used in stability studies to monitor impurity levels under various stress conditions as per ICH guidelines.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Employed by quality control (QC) laboratories for routine batch release testing of Trazodone API.
• Utilized by contract research organizations (CROs) and testing laboratories offering analytical services to the pharma industry.

Basic Information

Product Name	Trazodone Impurity A
CAS No.	55290-66-9
Molecular Formula	C19H22ClN5O
Molecular Weight	371.86 g/mol
Synonyms	1-{3-[4-(3-Chlorophenyl)-1-piperazinyl]propyl}-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one; Trazodone Related Compound A; Trazodone Impurity 1; Trazodone EP Impurity A; Trazodone USP Related Compound A; 3-(2H)-Triazolo[4,3-a]pyridin-3-one, 1-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-; UNII-4J8V4P6H6R
EINECS	Contact for details

Quality Control

Our Trazodone Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile. We support compliance with major pharmacopoeial standards, including USP and EP monographs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.